FDA Alerts

Philips Respironics, Inc. Updates Use Instructions for OmniLab Advanced+ (OLA+) Ventilator due to Interruptions and/or Loss of Therapy

Tue Jul 02 2024By FDA

Philips Respironics, Inc. is updating use instructions for OmniLab Advanced+ (OLA+) Ventilator due to a failure in the Ventilator Inoperative alarm, which can cause therapy interruption or loss. Philips will correct the affected OLA+ to address the Ventilation Inoperative Alarm issue with a software patch. Alternately, Philips will offer a replacement device until these affected OLA+ devices are corrected.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices without following the updated instructions may cause serious injuries or death.

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Questions?
If you have questions about this recall, contactPhilips Respironics, Inc.at1-800-345-6443, prompts 4, 5 or email at respironics.clinical@philips.com.

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